Lehman College

The City University of New York

Investigator: / Your name / Institutional Contact: / Lois Levy, LCSW
Title / IRB Administrator
Address / Shuster Hall, Room 330
Lehman College/CUNY / Lehman College/CUNY
Bronx, NY 10468 / Bronx, NY 10468
(718) 960- / (718) 960-8717

CONSENT FORM

TITLE OF PROJECT: Put your title here

PURPOSE OF THE STUDY

You are being asked to participate in a research study. The purpose of this study is write in your purpose. You qualify for participation in this study because write in why they qualify.

DESCRIPTION OF THE RESEARCH

Give a step by step description chronologically of what the subject will be asked to do. End section with a statement of how long a session takes and/or how many sessions it will take the subject to complete their part of the research. Indicate what if any procedures are experimental.

COSTS OR REIMBURSEMENTS (Delete if you are not paying the subjects)

If payment or other compensation is being offered, state: You will be paid $______or given ______in order to compensate for your time and effort.

POTENTIAL RISKS OR DISCOMFORTS

Risk may be emotional, social, financial or physical. If there is a risk that the study might evoke an emotional reaction, include a name and number for a counseling facility. Let the facility know about the study before the study begins

POTENTIAL BENEFITS

If there are no direct benefits, the investigator may tell subjects what he or she hopes to learn, how that knowledge will contribute to the field of study, or may benefit others if, indeed, such a case can be made.

ALTERNATIVES TO PARTICIPATION (Delete if there are no alternatives)

This requirement is primarily relevant for biomedical research. However, it might be applicable to social and behavioral research if behavioral interventions are proposed.

CONFIDENTIALITY

Your identity as a participant in this research study will be kept confidential in any publication of the results of this study. The information obtained during this research study will be kept confidential.

·  Explain how confidentiality will be maintained. For example, “In order to ensure that your answers will remain confidential, please do not put your name on the questionnaire you receive. That way no one, including the research staff, will know how you, as an individual answered. Questionnaires will only be identified by anonymous subject numbers. No one will see the completed questionnaires except for members of the research team.”

·  Explain who will have access to the data during and after the study

·  Explain how the data will be stored

·  Explain what will happen to the data after the study is completed.

·  If you will be audio or videotaping subjects include a statement that the subjects will be audio/video taped, who will have access to the tapes and when the tapes will be destroyed

·  Explain how the tapes will be stored and whether they will be seen by persons other than the researcher.

·  Include a full disclosure of reporting requirements, such as with child abuse if that is a possibility with the study.

VOLUNTARY PARTICIPATION

Your participation in this study is totally voluntary.

TERMINATION OF PARTICIPATION

You are free to withdraw consent and discontinue participating in this study at any time. You do not have to answer any questions that you prefer not to answer. Your decision to participate or not to participate will not in any way affect [choose whichever statement(s) is appropriate] your grades in this class; your standing in the college; your access to services from this agency; your job status. If the subject drops out of the study and would only receive partial compensation include this in this section.

CONTACT PERSON(S)

If you have any questions or concerns about this study or your rights as a participant please contact the principal investigator or the institutional contact person at the addresses and telephone numbers above.

I have read this consent form and I understand the procedure to be used in this study. I freely and voluntarily choose to participate. I understand that I may discontinue participation at any time.

Name (printed):

Signature: Date:

§  This is a sample consent for an individual 18 or older who is the subject of the research. Delete whatever is not relevant to your needs.
§  Consent Forms should include separate signature lines for each of the following:
§  Primary consent to participate in the research program
§  Consent for the PI or assistants to access subject medical/academic/other records
§  Consent for the PI or assistants to audio or video tape the subject
§  Consent for the PI or assistants to share data or records
§  Use common, non-technical language that can be clearly understood by the participants. Write at the 6th grade reading level.
§  Consent forms should be on Lehman College IRB letterhead and only one page long; if more space is needed, create a double-sided form rather than using legal size paper or two separate sheets of paper. Signature lines should be on the same page as the information.
§  Two consents, one for parents and one for the child, can be used when the research involves difficult topics such as sexual behavior.
Investigator: / Your name / Institutional Contact: / Lois Levy, LCSW
Title / IRB Administrator
Address / Shuster Hall, Room 330
Lehman College/CUNY / Lehman College/CUNY
Bronx, NY 10468 / Bronx, NY 10468
(718) 960- / (718) 960-8717

PARENTAL or GUARDIAN PERMISSION FORM

TITLE OF PROJECT: Put your title here

PURPOSE OF THE STUDY

Your child is being asked to participate in a research study. The purpose of this study is write in your purpose. Your child qualifies for participation in this study because write in why they qualify.

DESCRIPTION OF THE RESEARCH

Give a step by step description chronologically of what the subject will be asked to do. End section with a statement of how long a session takes and/or how many sessions it will take the subject to complete their part of the research. Indicate what if any procedures are experimental.

COSTS OR REIMBURSEMENTS (Delete if you are not paying the subjects)

If payment or other compensation is being offered, state: Your child will be paid $______or given ______in order to compensate for your time and effort.

POTENTIAL RISKS OR DISCOMFORTS

Risk may be emotional, social or financial. If there is a risk that the study might evoke an emotional reaction, include a name and number for a counseling facility. Let the facility know about the study before the study begins

POTENTIAL BENEFITS

If there are no direct benefits, the investigator may tell subjects what he or she hopes to learn, how that knowledge will contribute to the field of study, or may benefit others if, indeed, such a case can be made.

ALTERNATIVES TO PARTICIPATION (Delete if there are no alternatives)

This requirement is primarily relevant for biomedical research. However, it might be applicable to social and behavioral research if behavioral interventions are proposed.

CONFIDENTIALITY

Your child’s identity as a participant in this research study will be kept confidential in any publication of the results of this study. The information obtained during this research study will be kept confidential.

·  Explain how confidentiality will be maintained. For example, “In order to ensure that your answers will remain confidential, please do not put your name on the questionnaire you receive. That way no one, including the research staff, will know how you, as an individual answered. Questionnaires will only be identified by anonymous subject numbers. No one will see the completed questionnaires except for members of the research team.”

·  Explain who will have access to the data during and after the study

·  Explain how the data will be stored

·  Explain what will happen to the data after the study is completed.

·  If you will be audio or videotaping subjects include a statement that the subjects will be audio/video taped, who will have access to the tapes and when the tapes will be destroyed

·  Explain how the tapes will be stored and whether they will be seen by persons other than the researcher.

·  Include a full disclosure of reporting requirements, such as with child abuse if that is a possibility with the study.

VOLUNTARY PARTICIPATION

Your child’s participation in this study is totally voluntary.

TERMINATION OF PARTICIPATION

You or your child are free to withdraw consent and discontinue participating in this study at any time. Your child does not have to answer any questions that they prefer not to answer. Your child’s decision to participate or not to participate will not in any way affect [choose whichever statement(s) is appropriate] their grades in this class; their standing in the college; their access to services from this agency; their job status. If the subject drops out of the study and would only receive partial compensation include this in this section.

CONTACT PERSON(S)

If you or your child has any questions or concerns about this study or your rights as a participant please contact the principal investigator or the institutional contact person at the addresses and telephone numbers above.

PARENT’S PERMISSION

I have read this consent form and I understand the procedure to be used in this study. I freely and voluntarily give permission for my child to participate. I understand that my child may discontinue participation at any time.

Name (printed): ______

Signature: Date:

If two signatures are needed add name, signature and date lines for second person signing

CHILD’S ASSENT

I have read (or had this consent read to me) this consent form and understand what I am being asked to do. I freely and voluntarily agree to be in the study. I understand that I may drop out of the study at any time.

Name (printed):

Signature: Date:

Delete this box from consent

§  This is a sample consent. Delete whatever is not relevant to your needs. This would be the kind of consent you would need if your subject is a child under 18. You need the guardian’s permission and the child’s assent.
§  Consent Forms should include separate signature lines for each of the following:
§  Primary consent to participate in the research program
§  Consent for the PI or assistants to access subject medical/academic/other records
§  Consent for the PI or assistants to audio or video tape the subject
§  Consent for the PI or assistants to share data or records
§  Use common, non-technical language that can be clearly understood by the participants. Write at the 6th grade reading level. For younger children, change the wording so it is appropriate. It might need to say, “This consent was read to me…”
§  Consent forms should be on Lehman College IRB letterhead and only one page long; if more space is needed, create a double-sided form rather than using legal size paper or two separate sheets of paper. Signature lines should be on the same page as the information.
Two consents, one for parents and one for the child, can be used when the research involves difficult topics such as sexual behavior